1-Butanaminium, 4-hydroxy-N,N,N-trimethyl-4-oxo-, inner salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed under GLP and in accordance with OECD-/EU-testing guidelines

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Sponsor's identification: P5476
- Date received: 26-Oct-1993
- Description: colourless liquid
- Container: clear glass jar
- Storage conditions: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K
- Age at study initiation: approx. 5-8 weeks
- Weight at study initiation: males 161-169 g; females 140-150g
- Acclimation: 5 days
- Housing: housed in groups of up to five by sex in solid floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.
- Water (e.g. ad libitum): tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 44-58%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours darkness; 12 hours continuous light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

substance was used as such (40% aqueous solution)

Details on oral exposure:

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Doses:

Limit dose of 2000 mg/kg

No. of animals per sex per dose:

5 males & 5 females

Control animals:

no

Details on study design:

OBSERVATION:
The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.

NECROPSY:
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Preliminary study:

no pretest performed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
- Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No signs of systemic toxicity were noted at necropsy-

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: the aqueous solution does not have any classification/labelling requirements, whereas the concentrated test material has to be classified as harmful based on its estimated LD50 of > 400 mg/l

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute LD50 on Sprague Dawley rats was determined to be > 2000 mg/l for the aqeous solution. The LD50 for the concentrated test material was extrapolated to be > 400 mg/kg.

Executive summary:

The test was performed 1993 under GLP according to the EU satandard testing method B.1 (Directive 67/548/EEC). The study was performed on 5 male amd 5 female Sprague Dawley rats at a limit concentration of 2000 mg/kg test material. There were neither mortality nor clinical symptoms observed. No effects were seen also on body weights asnd at necropsy.